ASH 2024 | Cladribine with low-dose cytarabine & venetoclax alternating with azacitidine & venetoclax in AML

I’m glad to be here at ASH talking to you about one of our abstracts using lower intensity therapy with venetoclax. As you know, ven and HMA or venn and low-dose cytarabine are the standard of care for older patients with newly diagnosed AML. It has dramatically revolutionized the treatment of those patients. We have a new regimen that we’ve been using for many years at MD Anderson called cladribine and low-dose cytarabine. Again, it’s a very low intensity regimen, has no anthracycline, and uses low-dose cytarabine along with cladribine at a dose of 5 milligrams per meter squared daily for 5 days. To that regimen, we add venetoclax for 21 days during cycle 1, and then during cycle 2 and beyond, once the patient is in remission, we drop the dose of venetoclax to either 7 days if they have MRD negativity, or 14 days if they’re still MRD positive. We alternate two cycles of cladribine, low-dose cytarabine, and venetoclax. I call it CLAD-LDAC because it’s easier to say with a Vidaza and venetoclax for two cycles, back and forth. We used to give up to 18 cycles of this regimen, owing to the fact that we wanted to have some sort of long-term maintenance strategy. We realized that most patients got less than 10 cycles and even less than eight cycles of therapy. So we amended the protocol now only give up to six cycles of therapy and then patients then either move on to allogenic stem cell transplantation somewhere along their journey or they get some sort of maintenance therapy that could be oral AZA or can be protocol maintenance therapy such as HMA and venetoclax. So with this regimen in older patients with a median age of 69 years we saw a response rate as complete remission plus CRi rate of 86% and among those 76% had MRD negative complete remission. So outstanding outcomes and higher than what we typically see with HMA and venetoclax in this older patient population. 44% of these patients were able to get to stem cell transplantation. That tells you that these are not only older and frail patients but they were older patients who may have been potentially eligible for intensive chemotherapy but who many of us aren’t thrilled about giving 7 + 3 to a 60 year old or 64 year old who may not be in the best shape but they were still able to to get to stem cell transplantation and saw an improved outcome with stem cell transplantation. The long-term survival in this study at one and four years was 53% at four years and 65% at one year survival in this patient population. This is now with long-term follow-up and over 140 patients treated with this regimen. So we’re very excited about this regimen, high rates of remission, high rates of MRD negativity, able to get stem cell transplant and potentially helping replace front line regimens such as intensive chemotherapy for that older population or maybe even HMA-VEN for that older population where you think you can give a little bit more and get them into a deeper remission.

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